Quality of LifeNCT06319352
Evaluation of Quality-of-Life Improvements Using UroShield Device
A study testing Active UroShield in people with Quality of Life and Catheter-Associated Urinary Tract Infection, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Catheter-Associated Urinary Tract Infection
- What is being tested?
- Active UroShield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18+
- Indwelling urinary catheter (urethral or suprapubic) in place
- Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
- Able to comply with the requirements of the study
Who cannot join
- Pregnant or breastfeeding women
- Antibiotic use in past 10 days
- Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
- Participation in another drug or device study in past 30 days
- History of poor compliance to medical treatment regimens
- Conditions that may severely compromise their ability to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Quality-of-Life Improvements Using UroShield for Patients Living in Long Term Care Facilities With Indwelling Urinary Catheters - A Pilot Study
The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.
The main questions the investigators aim to answer focus on implementation and practicality:
Read more
- Recruitment feasibility and time to recruit
- How well do participants adhere to device protocol?
- How often do device components (i.e., actuators and drivers) have to be replaced?
- How much time is required for data collection and what sources or methods for data collection are used?
Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.
Read the detailed description
The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.
This double-blind pilot study aims to recruit 10-20 participants with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Participants providing consent will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).
- Being tested
- Active UroShield, Sham UroShield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active UroShieldDevice
Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
Sham UroShieldDevice
Participants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device.
| Study group | Role | What they receive |
|---|---|---|
| Active UroShield | Experimental | Active UroShield Device Receives: Device: Active UroShield |
| Sham UroShield | Sham comparator | Inactive UroShield device Receives: Device: Sham UroShield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Measured by Recruitment rate
Feasibility was determined by the number of participants enrolled out of the number of participants eligible to participate in the study.
Measured: Summarized every month for 6 months, or until the recruitment goal is reached.
Secondary outcomes (3)
Device use adherence
Number of patients with at least 80% adherence out of total patients enrolled. Device adherence will be assessed via direct observation by study staff as well as patient/caregiver/clinician-reported (via written documentation or phone/email correspondence).
Measured: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Device accountability
Number of devices used out of the number of devices received. Extra components of the device (i.e., actuators) will be available to the study team; monitoring their use will validate amount and type of resources needed for intervention implementation.
Measured: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Efficiency of data collection
Time required for survey completion and data abstraction via chart review (actual time/expected time).
Measured: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start29 Apr 2024
- Primary completion18 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Nanovibronix
- Responsible party
- Principal investigator, Lona Mody, University of Michigan
- Investigators
- Lona Mody, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319352
- Sponsor's protocol ID
- HUM00243293
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality-of-Life Improvements Using UroShield for Patients Living in Long Term Care Facilities With Indwelling Urinary Catheters - A Pilot Study
- ClinicalTrials.gov ID
- NCT06319352
- Acronym / sponsor ID
- HUM00243293
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Nanovibronix
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.
The main questions the investigators aim to answer focus on implementation and practicality:
- Recruitment feasibility and time to recruit
- How well do participants adhere to device protocol?
- How often do device components (i.e., actuators and drivers) have to be replaced?
- How much time is required for data collection and what sources or methods for data collection are used?
Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.
Detailed description
The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.
This double-blind pilot study aims to recruit 10-20 participants with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Participants providing consent will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active UroShield | Experimental | Device: Active UroShieldActive UroShield Device |
| Sham UroShield | Sham comparator | Device: Sham UroShieldInactive UroShield device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female age 18+
- Indwelling urinary catheter (urethral or suprapubic) in place
- Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
- Able to comply with the requirements of the study
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Antibiotic use in past 10 days
- Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
- Participation in another drug or device study in past 30 days
- History of poor compliance to medical treatment regimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active UroShieldParticipants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube. | Device | Active UroShield |
| Sham UroShieldParticipants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device. | Device | Sham UroShield |
Primary outcome
Feasibility as Measured by Recruitment rate
Time frame: Summarized every month for 6 months, or until the recruitment goal is reached.
Feasibility was determined by the number of participants enrolled out of the number of participants eligible to participate in the study.
3 secondary outcomes
Device use adherence
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Device accountability
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Efficiency of data collection
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lona Mody principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active UroShield in people with Quality of Life and Catheter-Associated Urinary Tract Infection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by Recruitment rate (time frame: Summarized every month for 6 months, or until the recruitment goal is reached.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.